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Trifluridin/tipirACil in meTastatIc Colorectal Cancer (TACTIC)

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ClinicalTrials.gov Identifier: NCT03665506
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
iOMEDICO AG
Information provided by (Responsible Party):
Servier

Brief Summary:
A non-interventional, prospective, open, multicenter study in Germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Drug: Trifluridin/Tipiracil

Detailed Description:
The purpose of this NIS, after market approval of trifluridin/tipiracil as treatment for mCRC patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, QoL, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. In addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/Tipiracil in Patients With Metastatic Colorectal Cancer
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Trifluridin/Tipiracil
    QoL assessment
    Other Name: QoL assessment


Primary Outcome Measures :
  1. Overall survival [ Time Frame: Baseline up to 3 years ]
    time from first administration of trifluridin/tipiracil to death from any cause


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Baseline up to 3 years ]
    PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause

  2. Overall response rate [ Time Frame: Baseline up to 3 years ]
    ORR: the proportion of patients whose best response was a complete or partial response

  3. Disease control rate 8 weeks [ Time Frame: Baseline up to 3 years ]
    DCR-8: the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 8 weeks after first administration of trifluridin/tipiracil

  4. Trifluridin/tipiracil treatment details [ Time Frame: Baseline ]
    Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen)

  5. Trifluridin/tipiracil treatment details [ Time Frame: Baseline up to 3 years ]
    Treatment duration

  6. Trifluridin/tipiracil treatment details [ Time Frame: Baseline up to 3 years ]
    Dose intensity (absolute and relative)

  7. Trifluridin/tipiracil treatment details [ Time Frame: Baseline up to 3 years ]
    Treatment sequence (previous and subsequent therapies in relation to Trifluridin/Tipiracil treatment) (Descriptive statistics using frequency tables will be used to assess previous and subsequent palliative systemic antineoplastic treatment regimen used.)

  8. AEs and SAEs according to NCI CTCAE [ Time Frame: Baseline up to 3 years ]
    AEs and SAEs according to NCI CTCAE

  9. Safety laboratory values of participants [ Time Frame: Baseline up to 3 years ]
    By-patient display of all safety laboratory results captured as per clinical routine (e.g. CEA, CA 19-9, haemoglobin, neutrophils absolute, lymphocytes count, platelets count, leukocytes count, alkaline phosphatase, ALT (GPT), AST (GOT), bilirubin total and serum creatinine). In addition, CTCAE grades of neutrophils, white blood cell count, platelets, haemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase and creatinine will be presented using frequencies and percentages for each visit. Shift tables opposing CTCAE grades during treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages.

  10. Therapy management (use of relevant supportive medications) [ Time Frame: Baseline up to 3 years ]
    Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies)

  11. Patient-reported outcomes (PROs) on quality of life (QoL) [ Time Frame: Baseline up to 3 years ]
    PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine patients' symptomatic toxicity. Item cluster scores of PRO-CTCAE questionnaire at each visit and change from baseline of scores.

  12. Patient-reported outcomes (PROs) on quality of life (QoL) [ Time Frame: Baseline up to 3 years ]
    EQ-5D-5L: Questionnaire EQ-5D-5L is used to determine patients' health related quality of life. EQ-5D-5L index and visual analogue score at each visit and change from baseline for both, index and visual analogue score.


Other Outcome Measures:
  1. Time to deterioration of the ECOG performance status [ Time Frame: Baseline up to 3 years ]
  2. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Incidence of hospitalization (Frequencies)

  3. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Frequency of hospitalization (Frequencies)

  4. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Total duration of hospital stays per patient (descriptive statistics)

  5. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Reasons for hospitalizations per patient and per case (Frequencies)

  6. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Number of consultations of various medical specialists

  7. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Incidence of home care (Frequencies)

  8. Assessment of health economic parameters [ Time Frame: Baseline up to 3 years ]
    Location of terminal care (Frequencies)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF (vascular endothelial growth factor) agents, and anti-EGFR (epidermal growth factor receptor) agents and with decision for treatment with trifluridin/tipiracil.
Criteria

Inclusion Criteria:

  • Aged 18 years or older.
  • Patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
  • Indication for treatment as assessed by the treating physician.
  • Decision for treatment with trifluridin/tipiracil.
  • Signed written informed consent.
  • Criteria according to current Summary of Product Characteristics (SmPC) for patients treated with trifluridin/tipiracil.
  • Ability to read and understand German.

Exclusion Criteria:

  • Contraindications according to SmPC for metastatic colorectal cancer patients treated with trifluridin/tipiracil.
  • Participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665506


Contacts
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Contact: Frank Hartmann +49 151 52 62 73 81 frank.hartmann@servier.com
Contact: Cathrin Hogrefe, PhD +49 761 15 242 - 626 cathrin.hogrefe@iomedico.com

Locations
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Germany
Onkologische Schwerpunktpraxis Kurfürstendamm Recruiting
Berlin, Germany, 10707
Contact: Ingo Schwaner, MD    +49 30 887742570    ingo.schwaner@onkologie-kurfuerstendamm.de   
Sponsors and Collaborators
Servier
iOMEDICO AG

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Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT03665506     History of Changes
Other Study ID Numbers: IOM-040380
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Servier:
mCRC
Trifluridin/Tipiracil

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents